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Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval

Pharmaceutical Technology

The company claimed that the utmost benefit is reported in hormone-receptor positive (HR+) women and those who commence treatment with Nerlynx within a year of receiving trastuzumab-based therapy. Nerlynx is the first drug in Specialised Therapeutics’ therapeutic portfolio to obtain approval in the region.

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AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer

Pharmaceutical Technology

According to the trial data, Enhertu lowered disease progression or mortality risk by 50% compared with chemotherapy according to the physician’s choice in HER2-low metastatic breast cancer patients with hormone receptor (HR)-positive disease or HR-negative disease. months compared with 5.1 months for the chemotherapy arm.

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US FDA approves expanded indication for Lilly’s breast cancer therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for the expanded indication for Eli Lilly and Company ’s (Lilly) Verzenio (abemaciclib) to treat breast cancer patients. The post US FDA approves expanded indication for Lilly’s breast cancer therapy appeared first on Pharmaceutical Technology.

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AstraZeneca’s ATP inhibitor Truqap wins FDA approval in breast cancer  

Pharmaceutical Technology

Truqap is approved in combination with Faslodex for HR-positive/HER2-negative breast cancer patients in the US.

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AstraZeneca’s AKT Inhibitor Wins FDA Approval for Combo Breast Cancer Treatment

BioSpace

The company's Truqap, in combination with its endocrine therapy Faslodex, has been approved by the regulator for adult patients with advanced HR-positive breast cancer with specific biomarker alterations.

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FDA Approves

The Pharma Data

Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. 0.45]) and overall survival (OS) (HR=0.30 [95% CI, 0.15-0.59]) Based on exploratory analyses of rPFS and OS in the BRCA m and non- BRCA m subgroups (non- BRCA subgroup rPFS HR=0.77 [95% CI, 0.63-0.96]; In the U.S.,

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FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure

pharmaphorum

“Today’s approval means these demonstrated benefits can now help to address a significant unmet need for the approximately three million adults in the US with preserved ejection fraction, a form of heart failure that has very limited treatment options.” absolute risk reduction, 0.79